Enable Study Site Reporter

Learn how to update your Vault’s configuration to enable the Study Site Reporter feature.

About the Feature

Study site reporters were added in Vault Safety 20R1. Upgraded Vaults must perform the following configuration changes to enable this feature.

This feature allows Admins to set up Study Contact records, which users can then select as Site Reporters during Case intake. Upon Case promotion, all required details of the Site Reporter are automatically populated on the Case, increasing data entry efficiency and accuracy.

In 23R1, support for study site reporters on Inbox Items was added to Vault Safety. You must first contact Veeva Support to enable this feature in your Vault. Then, perform the 23R1 configuration.

Manage Studies: Set Up Study Site Reporters describes how to set up Study Site Reporters, once you enable this feature.

(23R1) Add the Site Reporter Field to the Inbox Item Layout

Perform the following steps to add the Site Reporter field to the Inbox Item Details section:

  1. In Admin, go to Configuration > Objects > Inbox Item > Layouts > Inbox Item Detail Page Layout.
  2. In the Details section, select the Edit icon.
  3. In the Fields dropdown, add Site Reporter between Study Arm and Worldwide UID.
  4. Select Done.
  5. Save the page.

Update the Study Detail Page Layout

To edit the Study object, in the Admin area, go to Configuration > Objects > Study.

On the Study > Layouts tab, open the Study Detail Page Layout, and then make the following updates:

Study Sites Section

Update the Study Sites section with the following settings:

  • Remove the Study field
  • Add the following fields:
    • Study Site Number
    • Site Name
    • Registration

Study Contacts Section

Insert a Study Contacts related object section with the following settings:

Label Type Creation Option Columns
Study Contacts Related Object: Study Person New Page
  • Name
  • Study Site
  • Person > Country
  • Person > Qualification
  • Person > Name (added automatically)

Configure the Study Site Object

The Study Site object is new for this feature. You must configure layouts, layout rules, and validation rules. To edit the Study Site object, in the Admin area, go to Configuration > Objects > Study Site.

Layout

On the Study Site > Layouts tab, open the Study Site Detail Page Layout, and then make the following updates:

Details Section

Update the Details section with the following settings:

  • Change the Section Layout to One Column.
  • Add the following fields:
    • Organization
    • Study
    • Study Site Number
    • Registration
    • Site
    • Site Name
    • Country
    • space

Study Contacts Section

Insert a new Study Contacts related object section with the following settings:

Label Type Creation Option Columns
Study Contacts Related Object: Study Person New Page Name

Layout Rules

Go to Study Site > Layouts > Study Site Detail Page Layout > Layout Rules, and then add the following layout rules:

Rule Label Hide the following Page Layout Items IF this Layout Rule Expression is TRUE
New Record
  • Type: Fields
  • Value: Site Name
 status__v != 'active__v' && status__v != 'inactive__v'
Workflow Timeline
  • Type: Sections
  • Value: Workflow Timeline
 not(isBlank(name__v))

Validation Rules

On the Study Site > Validation Rule tab, add the following validation rule:

Label Error Message Location Validation Expression
Site is Mandatory Please enter a Site. Site not(isBlank(site__vr.name__v))

Configure the Study Person Object

The Study Person object is new for this feature. You must configure field criteria VQL, layouts, and layout rules. To edit the Study Person object, in the Admin area, go to Configuration > Objects > Study Person.

Person Field VQL

On the Study Person > Fields tab, locate the Person field, and then modify the Criteria VQL as follows:

object_type__vr.api_name__v = 'study_person__v' and organization__v = {{this.organization__v}} and country__v = {{this.study_site__vr.country__v}}

Layout

Go to Case > Layouts > Study Person Detail Page Layout, and then update the Details section to include the following fields:

  • Change the Section Layout to One Column
  • Add the following fields:
    • Organization
    • Study
    • Study Site
    • Person
    • Name

Layout Rules

On the Study Person object, configure the Study Person Detail Page Layout to add the following layout rules:

Rule Label Hide the following Page Layout Items IF this Layout Rule Expression is TRUE
Workflow Timeline Section: Workflow Timeline not(isBlank(name__v))

Update the Person Object

You must update layouts, layout rules, and validation rules on the Person object. To edit the Person object, in the Admin area, go to Configuration > Objects > Person.

Layout

On the Person > Layouts tab, open the Person Detail Page Layout, and then edit the layout to insert the following sections:

Details

Insert a One Column Details section with the following fields:

  • Qualification
  • Title
  • First Name
  • Middle Name
  • Last Name
  • Organization
  • Department
  • Email
  • Telephone
  • Mobile
  • Fax
  • Language
  • space

Address

Insert a One Column Address section with the following fields:

  • Street Address
  • City
  • State/Province
  • Country
  • Postal Code
  • space

System Information

Insert a Two Column System Information section with the following fields:

  • Last Modified Date
  • Last Modified By
  • Status
  • Created Date
  • Created By
  • Name

Layout Rules

Go to Person > Layouts > Study Person Detail Page Layout > Layout Rules, and then add the following layout rule:

Rule Label Hide the following Page Layout Items IF this Layout Rule Expression is TRUE
New Record
  • Type: Sections
  • Value: System Information, Address
 status__v != 'active__v' && status__v != 'inactive__v'

Validation Rules

Go to Person > Validation Rules, and then delete the Country is Mandatory validation rule.

Update the Case Object

You must add the Study Site and Site Reporter fields to the Case layout:

  1. Go to Admin > Configuration > Objects > Case > Layouts > Case Page Layout.
  2. In the Study section, add the following fields:
    • Study Site
    • Site Reporter
  3. Select Save.

Update Permission Sets

On the Users & Groups > Permission Sets page, configure the following Object Permissions:

Case Field Permissions

  1. Go to the Case Intake Actions permission set, and then go to Objects > Case.
  2. Under Object Level Permissions, grant Edit access to the following fields:
    • Study Site
    • Site Reporter

Study Person Object Permissions

  1. Enable the permission to Read both the Study Person object and the Person > Study Person object type for the following permission sets:
    • Case Distribution Actions
    • Case Entry Actions
    • Case Intake Actions
    • Case Review Actions
    • Safety Operations Actions
    • Safety Writer
    • Submission Actions
  2. Enable the permissions to Read, Create, Edit, and Delete for both the Study Person object and the Person > Study Person object type for the following permission set:
    • Administration Actions